Newron Pharmaceuticals SpA

Newron Pharmaceuticals said it has received the anticipated written communication from the U.S. Food and Drug Administration regarding the clinical hold at U.S. study centers in its Phase 3 ENIGMA-TRS 2 study of evenamide, and is reviewing the feedback and preparing its response. The FDA's concern relates to the known risk that certain sodium channel blockers may trigger arrhythmias, and the agency noted four deaths among patients treated with evenamide across all clinical studies to date versus one death among placebo patients; three of the four evenamide deaths were considered unrelated by investigators, while one was deemed possibly related. Newron said the four deaths represent an incidence of 0.56% versus 0.27% for placebo, and that when adjusted for treatment duration the mortality rate was 1.31 per 100 patient-years for evenamide compared with 1.81 per 100 patient-years for placebo. The company said it has not observed a pattern of cardiac abnormalities or arrhythmias across more than 10,000 ECGs from approximately 700 evenamide-treated subjects, and is evaluating additional cardiac screening and monitoring measures for ENIGMA-TRS 2. Enrollment in ENIGMA-TRS 1 is expected to be completed by mid-October, with topline 12-week data expected in Q1 2027, while ENIGMA-TRS 2 enrollment continues outside the U.S. with additional clinical sites being added as planned.